A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab + Relatlimab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma

Conditions

Participants with completely resected Stage III or Stage IV melanoma

Brief summary

RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.

Detailed description

OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., DMFS, by investigator, is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drugrelated AEs, deaths, laboratory abnormalities, and other select AEs, in all treated participants., PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy.

Related papers

No related papers found yet.

Interventions

DRUGNivo 240 mg and Rela 80 mg per vial

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.	—

Secondary

Measure	Time frame
OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., DMFS, by investigator, is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drugrelated AEs, deaths, laboratory abnormalities, and other select AEs, in all treated participants., PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy.	—

Measure

Time frame

OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., DMFS, by investigator, is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy., Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drugrelated AEs, deaths, laboratory abnormalities, and other select AEs, in all treated participants., PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy.

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Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Norway, Romania, Spain, Sweden

Outcome results

None listed